Possible clinical effects of molecular hydrogen (H2) delivery during hemodialysis in chronic dialysis patients: Interim analysis in a 12 month observation

PLoS One. 2017 Sep 13;12(9):e0184535. doi: 10.1371/journal.pone.0184535. eCollection 2017.

Abstract

Background and aim: It is supposed that enhanced oxidative stress and inflammation are involved with the poor clinical outcomes in patients on chronic dialysis treatment. Recent studies have shown that molecular hydrogen (H2) is biologically active as an anti-inflammatory agent. Thus, we developed a novel hemodialysis (E-HD) system which delivers H2 (30 to 80 ppb)-enriched dialysis solution, to conduct a prospective observational study (UMIN000004857) in order to compare the long-term outcomes between E-HD and conventional-HD (C-HD) in Japan. The present interim analysis aimed to look at potential clinical effects of E-HD during the first 12 months observation.

Subjects and method: 262 patients (140, E-HD; 122, C-HD) were subjected for analysis for comprehensive clinical profiles. They were all participating in the above mentioned study, and they had been under the respective HD treatment for 12 consecutive months without hospitalization. Collected data, such as, physical and laboratory examinations, medications, and self-assessment questionnaires on subjective symptoms (i.e., fatigue and pruritus) were compared between the two groups.

Results: In a 12-month period, no clinical relevant differences were found in dialysis-related parameters between the two groups. However, there were differences in the defined daily dose of anti-hypertensive agents, and subjective symptoms, such as severe fatigue, and pruritus, which were all less in the E-HD group. Multivariate analysis revealed E-HD was an independent significant factor for the reduced use of anti-hypertensive agents as well as the absence of severe fatigue and pruritus at 12 months after adjusting for confounding factors.

Conclusion: The data indicates E-HD could have substantial clinical benefits beyond conventional HD therapy, and support the rationale to conduct clinical trials of H2 application to HD treatment.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / therapeutic use
  • Fatigue / drug therapy
  • Female
  • Humans
  • Hydrogen / administration & dosage
  • Hydrogen / adverse effects
  • Hydrogen / therapeutic use*
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Pruritus / drug therapy
  • Renal Dialysis / adverse effects
  • Renal Dialysis / methods*

Substances

  • Anti-Inflammatory Agents
  • Antihypertensive Agents
  • Hydrogen

Grants and funding

The study was conducted by funds from Nihon Trim Co.. Ltd., (www.hihon-trim.co.jp), and Generalbincorporated association of Electrolyzed Water-Hemodialysis Study group (www.ew-hd.org). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.